Perioperative Cerebrovascular Autoregulation Monitoring in Neurosurgical Patients

NCT04174001 | Recruiting

• 1 other identifier: P00031784
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

One of the challenges in pediatric anesthesiology is to ensure adequate cerebral perfusion pressure to prevent cerebral ischemia or hyperemia from pressure-passive perfusion. However, there is no optimal tool for longitudinally monitoring cerebral perfusion under general anesthesia (GA). In addition, the safe limits of blood pressure that maintains adequate cerebral perfusion in infants and children are not clear. Furthermore, patients with neurological impairments may have impaired cerebral auto-regulation (CA) function which may associated with functional outcomes. To address the critical public health issues associated with the safe use of general anesthesia in during neurosurgery, monitoring cerebral perfusion and oxygenation continuously during the peri-operative period. The investigators have pioneered a novel technology, diffuse correlation spectroscopy (DCS), to optically measure cerebral blood flow (CBF) non-invasively and demonstrated that it is safe and practical as a bedside CBF monitor in the NICU. Blood flow is distinct from blood oxygenation, but both are important for brain health. Clinical near infrared spectroscopy (NIRS) devices are available to monitor oxygenation by light absorption, but CBF must be monitored by light scattering, which is only available with research DCS devices. While the physical principles of the methods are different, the sensors for both techniques are very similar. The investigators have therefore combined DCS with advanced frequency-domain NIRS (FDNIRS) in a single device to simultaneously monitor cerebral tissue oxygen saturation (cStO2), blood volume (CBV), CBF and oxygen metabolism (CMRO2), which cannot be monitored with existing clinical devices. The investigators have previously shown that these measures are far more sensitive than cStO2 alone in several infant brain pathologies. In this study, the investigators aim to test the feasibility of integrating the FDNIRS-DCS technology into perioperative monitoring to study cerebral hemodynamics and oxygen metabolism continuously in children during general anesthesia and surgery. Additionally, the investigators will determine how anesthesia-related events affect cerebral hemodynamic instability and how anesthetic level correlates with CA functions in children.

Conditions

Cerebral Hemodynamics

Outcome Measures

Primary Outcomes (1)

• Changes in Cerebral Hemodynamics from baseline

  Changes in frequency domain near infrared spectroscopy - diffuse correlation spectroscopy (FDNIRS-DCS) measurements from baseline to determine what factors are correlated with changes in the cerebral hemodynamics and auto regulation. This will be monitored at baseline pre-operatively, intraoperatively, post-operatively while in-patient, and at follow-up visits for up to one year.

  Through study completion; on average one year

Study Arms (2)

Neuro group

Patients who meet the following criteria: * 18 years of age or younger * diagnosed with one or more of the following neurological disorders: moyamoya disease, congenital anomalies of the brain, hypoxic-ischemic encephalopathy, brain tumor, Chiari malformation, epilepsy and stroke * planned for any surgical procedures that require general anesthesia * planned to receive intraoperative and/or postoperative invasive arterial blood pressure monitoring Patients who have a surgical procedure that contraindicates the placement of a NIRS probe on the forehead or are scheduled for a cardiac procedure will be excluded.

Control group

Patients who meet the following criteria: * 18 years of age or younger-planned for any surgical procedures that require general anesthesia * planned postoperative invasive blood pressure monitoring Patients who have a surgical procedure that contraindicates the placement of a NIRS probe on the forehead or have symptoms of neurological disorders will be excluded.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We plan to enroll 20 subjects for the Neuro group and 10 subjects for the Control group.

You may qualify if:

• years of age or younger
• diagnosed as one or more of the neurological disorders, including but not limiting to moyamoya disease, congenital anomalies of the brain, hypoxic-ischemic encephalopathy, brain tumor, Chiari malformation, epilepsy and stroke (NEURO GROUP ONLY)
• planned for any surgical procedures that required general anesthesia (CONTROL GROUP ONLY)
• planned for any surgical procedures that required general anesthesia
• planned to receive intraoperative and/or postoperative invasive arterial blood pressure monitoring.

You may not qualify if:

• surgical procedure contraindicates the placement of NIRS probe on the forehead
• scheduled for a cardiac procedure.
• symptoms of neurological disorders (CONTROL GROUP ONLY)

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

• Craig McClain

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Craig McClain, MD

CONTACT

617-355-7737; Craig.McClain@childrens.harvard.edu

Rachel Bernier

CONTACT

857-218-5348; rachel.bernier@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: November 22, 2019
• Study Start: February 11, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)